Attorney:
Richard D. Kelly
November 21, 2022
While an adequate written description is essential for patentability, 35 U.S.C. § 112(a), like everything else too much can have adverse consequences as uniQure biopharma recently learned in IPR2021-00926 (IPR) involving U.S.P. 9,982,248 (‘248).<... Read more
Attorney:
Marina I. Miller, Ph.D.
October 26, 2022
Mylan Pharmaceuticals, Inc. (“Mylan”) appealed from the final written decision of the USPTO Patent Trial and Appeal Board (the “Board”) holding that Mylan failed to show that claims 1–4, 17, 19, and 21–23 of U.S. Patent 7,326,708 (the “’708 patent”) were anticipated or would have been obvious over the cited prior art.<... Read more
Attorney:
Richard D. Kelly
October 5, 2022
The Supreme has relisted the petition for certiorari in Juno Therapeutics, Inc. v. Kite Pharma, Inc., 21-1566 where Juno petitioned for review of the Federal Circuit’s decision reported at 10 F.4th 1330 (2021) reversing the decision of the lower court finding U.S.P. 7,446,190 to not be invalid for lack of written description or enablement and awarding damages of over $1.2 billion. While the relisting of a certiorari petition does not guarantee cert will be granted, statically since 2016 between about 30 and 40% of relisted petitions have been granted. The SCOTUS blog has detailed analysis here. Considering that the overall grant rate for petitions is only about 4% this indicates that the Juno petition has a much greater than normal possibility of being granted.<... Read more
Attorney:
Richard D. Kelly
October 3, 2022
Just two days after the Federal Circuit denied a stay of its mandate in Novartis v. HEC Pharm Co., Ltd., the Supreme Court granted a stay of the mandate pending a further order of the Court and requiring HEC to file a response to the Novartis stay request.<... Read more
Attorney:
Marina I. Miller, Ph.D.
September 6, 2022
Kamstrup A/S appealed a final written decision of the Patent Trial and Appeal Board (“the Board”). The Board found claims 1–15 of Kamstrup’s U.S. Patent No. 8,806,957 unpatentable as obvious or anticipated. On appeal, Kamstrup challenged the Board’s claim constructions. In addition, Kamstrup challenged the Board’s anticipation and obviousness determinations largely on the basis that the Board erred in rejecting Kamstrup’s claim construction arguments.<... Read more
Attorneys:
Richard D. Kelly and Elissa Sanford
August 12, 2022
When it comes to IPR petitions filed in the Bio/Pharma space, USPTO data tells us that while Bio/Pharma petitions make up only 8% of the total petitions filed for the fiscal year of 2022 (through June 30, 2022), there is a high intuition rate for those Bio/Pharma petitions. According to USPTO statistics, 80% of the Bio/Pharma cases have been instituted so far this year. Put differently, 59 of the 74 petitions reviewed were subsequently granted.<... Read more
Attorney:
Richard D. Kelly
August 9, 2022
On July 11, Teva filed its petition for certiorari from the Federal Circuit’s second decision in its “skinny label” litigation with GSK, 7 F.4th 1320 (Fed, Cir. 2022). The petition makes many of the same arguments that Teva made before the Federal Circuit but the inconsistency of the Federal Circuit’s decision in GSK with three prior decisions standout. Its yet another example of the Federal Circuit’s lack of discipline in following its own precedent. While Teva rightly complains that the decision creates uncertainty around the skinny label provisions of 21 U.S.C. § 355(j)(2)(A)(viii), the real uncertainty is created by the Federal Circuit’s unfortunate habit of ignoring its own precedent upon which parties rely in making decisions.<... Read more
Attorney:
Richard D. Kelly
May 16, 2022
Congress sought to keep Patent Office delays from prejudicing a patentee by granting PTA to compensate for the Patent Office delays. While one might expect the Patent Office to work mightily to avoid administrative delays in prosecution, today the average time to first action is about 17 months, three months longer than the target of 14 months adding on average 3 months to the patent term. Other delays during prosecution add still more time to the PTA period. Since these are averages, the additional time can be significant. In pharmaceuticals the PTA added for delays of even a few months can mean hundreds of millions of dollars in revenue. The two district courts have addressed this issue where an ODP defense is raised against the later expiring patent because of PTA and came to different conclusions. See Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc., 533 F. Supp. 3d 170 (D.N.J. 2021) (the judicially created ODP does not trump the statutory PTA) and Mitsubishi. Magna Elecs., Inc. v. TRW Automotive Holdings Corp., No. 12-cv-654, 2015 WL 11430786 (W.D. Mich. Dec. 10, 2015) (ODP trumps PTA).<... Read more
January 25, 2022
Conclusion
Okay, let’s get this out of the way up front. The answer is maybe… but only with a lot more work and with substantially reduced claim scope.<... Read more
Attorney:
Elissa Sanford
December 13, 2021
On Dec. 1, 2021, the Federal Circuit held that Moderna lacked standing in an appeal from a Patent Trial and Appeal Board (“PTAB”) decision against rival Arbutus where the PTAB determined U.S. Patent No. 9,364,435 (“the ’435 patent”) was not unpatentable as obvious.[1] The ’435 patent concerns vaccine delivery technology, particularly a lipid nanoparticle delivery system used to protect nucleic acids delivered to cells as utilized in vaccines including Moderna’s COVID-19 vaccine.<... Read more